Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2031

Conditions
Breast Neoplasms
Interventions
PROCEDURE

Sentinel Lymph Node Biopsy (SLNB)

A sample of the participant's tumor-draining lymph nodes will be collected and sent to the biotherapy center for LNL isolation and expansion.

DRUG

Doxorubicin

Doxorubicin will be administered at 60 mg/m\^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study.

DRUG

Epirubicin

Epirubicin will be administered at 100 mg/m\^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered at 600 mg/m\^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered at 500 mg/m\^2 IV daily for three days. Cyclophosphamide will be initiated five days prior to the anticipated LNL transfer, and the precise timing will depend on the rate of in vitro LNL growth.

DRUG

Fludarabine

Fludarabine will be administered at 30 mg/m\^2 IV daily for three days. Fludarabine will be initiated five days prior to the anticipated LNL transfer, and the precise timing will depend on the rate of in vitro LNL growth.

BIOLOGICAL

Tumor-draining lymph node-derived lymphocyte (LNL)

Participants receive single infusion of LNL at the recommended phase 2 dose (RP2D).

BIOLOGICAL

Interleukin-2

Eight to twelve hours after completing the LNL infusion, all participants will receive intermediate-dose decrescendo IL-2 IV.

DRUG

Nab-paclitaxel

Nab-paclitaxel will be administered at 260 mg/m\^2 IV on Day 1 of Cycles 3-6 of the neoadjuvant chemotherapy of the study.

Trial Locations (1)

510120

RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER